A Phase 2/3 interventional study of Enlicitide Decanoate and Placebo in Heterozygous Familial Hypercholesterolemia (HeFH), sponsored by Merck Sharp & Dohme LLC. Recruiting at 48 sites in 20 countries. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 2/3, Interventional, and Treatment
This study is designed to learn if enlicitide decanoate is safe and effective to treat children and adolescents with heterozygous familial hypercholesterolemia (HeFH) and high amounts of low-density lipoprotein cholesterol (LDL-C) in the blood.
The goals of this study are to learn about the safety of enlicitide and if children tolerate it, what happens to enlicitide in a child's body over time, and if enlicitide works to lower cholesterol levels in children more than a placebo.
249 studies on the registry are indexed under Hyperlipoproteinemia Type II; 56 are open to participants now.
This study's planned enrollment of 153 is above the median of 134 across 178 interventional studies indexed under Hyperlipoproteinemia Type II.
Browse Hyperlipoproteinemia Type II studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 132 are open to participants now.
Of its 501 completed or terminated interventional studies of FDA-regulated products, 370 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Inclusion criteria include, but are not limited to:
Is receiving either:
Exclusion Criteria:
Exclusion criteria include, but are not limited to:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive enlicitide decanoate orally once daily (QD) at a dosage determined by age for up to 2 weeks.
Drug: Enlicitide Decanoate
Participants receive enlicitide decanoate QD at a dosage determined by age for up to 24 weeks.
Drug: Enlicitide Decanoate
Participants receive placebo orally QD for up to 24 weeks.
Drug: Placebo
Participants who complete either Part A or Part B may enroll in this open-label extension arm. Participants in the extension arm receive enlicitide decanoate QD at a dosage determined by age for up to 3 years.
Drug: Enlicitide Decanoate
Enlicitide decanoate taken by mouth
Also known as: MK-0616, Enlicitide
Placebo tablet matched to enlicitide decanoate taken by mouth
Part A: Maximum Plasma Concentration (Cmax) of Enlicitide
Blood samples will be collected to determine the Cmax of enlicitide.
Time frame: At designated timepoints (up to 24 hours postdose on day 14)
Part A: Area Under the Concentration-Time Curve from 0 to 24 Hours (AUC0-24) of Enlicitide
Blood samples will be collected to determine the AUC0-24 of enlicitide.
Time frame: At designated timepoints (up to 24 hours postdose on day 14)
Part B: Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
Blood samples will be collected to determine the percent change from baseline in LDL-C.
Time frame: Baseline and Week 24
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: Up to approximately 188 weeks
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: Up to approximately 180 weeks
Part B: Percent Change from Baseline in Apolipoprotein B (ApoB)
Blood samples will be collected to determine the percent change from baseline in apolipoprotein B.
Time frame: Baseline and week 24
Part B: Percent Change from Baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C)
Blood samples will be collected to determine the percent change from baseline in non-HDL-C.
Time frame: Baseline and week 24
Part B: Percent Change from Baseline in Lipoprotein (a) (Lp(a))
Blood samples will be collected to determine the percent change from baseline in Lp(a).
Time frame: Baseline and week 24
Part B: Percentage of Participants With LDL-C <130 mg/dL at Week 24
The percentage of participants with LDL-C \<130 mg/dL at week 24 will be reported.
Time frame: Week 24
Part B: Percentage of Participants With ≥50% LDL-C Reduction from Baseline at Week 24
The percentage of participants with ≥50% LDL-C reduction from baseline at week 24 will be reported.
Time frame: Baseline and week 24
Part B: Percentage of Participants With LDL-C <100 mg/dL at Week 24
The percentage of participants with LDL-C \<100 mg/dL at week 24 will be reported.
Time frame: Week 24
Change in Carotid Intima-media Thickness (cIMT)
Ultrasound measurements will be performed to determine the change from baseline in cIMT.
Time frame: Baseline and week 24
Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · externaldatasharing-msd.com
Started Aug 2025 (actual). Primary completion is estimated for Dec 2033, 99 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: MK-0616
Hyperlipoproteinemia Type II →